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Clinical Trial Details

Trial ID: L2097
Source ID: NCT00759720
Associated Drug: Tak-559 And Glyburide
Title: Efficacy and Safety of TAK-559 Combined With Glyburide in Treating Subjects With Type 2 Diabetes Mellitus.
Acronym: ORIGAMI
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: TAK-559 and glyburide|DRUG: TAK-559 and glyburide|DRUG: Glyburide
Outcome Measures: Primary: Change from Baseline in Glycosylated hemoglobin level., Final Visit | Secondary: Change from baseline in Glycosylated hemoglobin level., Weeks: 4, 8, 12, 16 and 20.|Change from baseline in Fasting plasma glucose., At all Visits.|Change from Baseline in Serum insulin., Weeks: 4, 12, 16, 20 and Final Visit.|Change from Baseline in C-peptide., Weeks: 4, 12, 16, 20 and Final Visit.|Change from Baseline in Lipids (triglyceride, total cholesterol, high-density lipoprotein, low-density lipoprotein and very low-density lipoproteins), Weeks: 12, 16, 20 and Final Visit.|Change from Baseline in Apolipoproteins [A1 and B])., Final Visit|Change from Baseline in Free fatty acids., Weeks: 12, 16, 20 and Final Visit.|Markers of thrombosis (plasminogen activator inhibitor-1 and fibrinogen)., Weeks: 4, 12, 16, 20 and Final Visit.|Markers of inflammation (interleukin-6 and C-reactive protein)., Weeks: 4, 12, 16, 20 and Final Visit.|Urinary albumin/creatinine ratio., Weeks: 4, 12, 16, 20 and Final Visit.|Low-density lipoprotein fractionation [L-DL particles (total), intermediate-density lipoprotein, large L-DL, small L-DL (total), medium-small L-DL, very-small L-DL, mean L-DL size]., Weeks 12, 16, 20, and Final Visit
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 447
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2003-11
Completion Date: 2004-12
Results First Posted:
Last Update Posted: 2012-02-02
Locations:
URL: https://clinicaltrials.gov/show/NCT00759720